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U.S. Department of Health and Human Services

Product Classification

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Device material, impression
Regulation Description Impression material.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeELW
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Dental Devices Branch (DEDB)
Submission Type 510(k)
Regulation Number 872.3660
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Dental Impression Materials - Premarket Notification; Final [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073959.htm] 
Third Party Review
Accredited Persons

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